Loading guide lumen

ABSTRACT

An apparatus is disclosed including: an intracardiac pump device having a path for a guidewire extending through the pump device from a first opening to a second opening; and a lumen which extends from a first end located outside of the pump device, into the pump device through the first opening in the pump device, along the path for the guidewire, out of the pump device through the second opening, and to a second end located outside of the pump device. The lumen is configured to receive the guidewire such that when the guidewire passes through the lumen from the first end to the second end, the guidewire is positioned along the path.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims a priority benefit, under 35 U.S.C. §120,as a continuation application of U.S. patent application Ser. No.13/552,366, filed Jul. 18, 2012, and entitled “LOADING GUIDE LUMEN. U.S.patent application Ser. No. 13/552,366 is a continuation of U.S. patentapplication Ser. No. 13/309,184, filed Dec. 1, 2011, which claimsbenefit of U.S. Provisional Application No. 61/418,735 filed Dec. 1,2010. The entire contents of the foregoing applications are herebyincorporated by reference herein.

BACKGROUND

An intracardiac blood pump is a blood pump that is at least partiallyintroduced into the heart to deliver blood from the heart into anartery, wherein the pump may protrude through a surgical opening in theheart. Typical intracardiac blood pumps have a maximum outer diameter ofabout 10-15 mm. A special form of intracardiac blood pumps areintravascular blood pumps. They are introduced into the heart throughthe vascular system of the patient, the incision site being spaced fromthe heart. Typically, intracardiac blood pumps inserted (e.g.,percutaneously) into a patient's body are highly miniaturized, with amaximum outer diameter of 8 mm or less. In many cases, the introductionof an intravascular pump device involves the use of a guidewire toposition the device.

Examples of intracardiac and intravascular blood pumps may be found inthe following references, the entire contents of each of which isincorporated by reference herein: International PublicationWO/2005/016416, published Apr. 20, 2006, International PublicationWO/2005/016416, published Feb. 24, 2005; International PublicationWO/2002/043791, published Jun. 6, 2002; International PublicationWO/2002/015963, published Feb. 28, 2002; International PublicationWO/2001/039817, published Jun. 7, 2001; and International PublicationWO/1999/058170 published Nov. 18, 1999.

Further examples include the family of blood pumps available fromAbiomed, Inc. of Danvers, MA under the Impella brand, including theImpella 2.5 pump, the Impella 5.0 pump, and the Impella LD.

SUMMARY

Medical devices, such as intracardiac blood pumps may be introduced intoa patient (e.g., percutaneously) using a guide wire. In some cases, thedevice is loaded onto the guidewire by passing the guidewire through thedevice. Typically, the guidewire must follow a selected guidewire paththrough the device, in order to avoid damaging the device, and to ensureproper operation of the guidewire. The applicants have realized that thetechniques described herein may be used to provide a guidewire loadinglumen which can be used to improve the ease and reliability of loadingthe device onto the guidewire. The lumen extends through the devicealong a desired guidewire path. A guidewire may then be threaded throughthe lumen by a practitioner performing the introduction operating,ensuring that the guidewire is properly positioned through the device.The lumen may then be removed prior to introduction of the device intothe patient.

In one aspect an apparatus is disclosed including: an intracardiac pumpdevice having a path for a guidewire extending through the pump devicefrom a first opening to a second opening; and a lumen which extends froma first end located outside of the pump device, into the pump devicethrough the first opening in the pump device, along the path for theguidewire, out of the pump device through the second opening, and to asecond end located outside of the pump device. In some embodiments, thelumen is configured to receive the guidewire such that when theguidewire passes through the lumen from the first end to the second end,the guidewire is positioned along the path.

In some embodiments, the lumen is configured such that, after theguidewire is received by the lumen and positioned along the path for theguidewire, the lumen may be removed without disturbing the guidewirefrom the path.

Some embodiments include a label attached to the second end of thelumen, where the label includes instructions for placing the guidewirealong the path using the lumen.

In some embodiments, at least a portion of the lumen has a color whichdiffers from the color of the pump device.

In some embodiments, the lumen is configured to allow the guide wire tobe positioned through the device along the path without substantiallyflexing the guidewire.

In some embodiments, the pump device includes: a proximal drive portionincluding a motor; a distal pump portion connected to a distal end ofthe drive portion; one or more discharge ports positioned between thedrive portion and the pump portion; an inflow cannula connected to thedistal end of the pump portion, the cannula having a distal endincluding an inflow opening; and a flexible tubular pigtail extensionconnected to the distal end of the inflow cannula. In some embodiments,the guidewire path runs through the tubular pigtail extension, from thepigtail extension into the inflow cannula, through the inflow cannulainto the pump portion, and out through a selected one of the one or moredischarge ports. In some embodiments, the lumen extends from a first endlocated outside of the pump device, into the pump device through thefirst opening in the pigtail extension, along the path for theguidewire, out of the pump device through the second opening includingthe selected one of the one or more discharge ports, and to a second endlocated outside of the pump device.

In some embodiments, the second end of the lumen extends at least about0.1 cm, 0.5 cm, 1.0 cm, 2.0 cm, 5.0 cm or more (e.g. in the range of0.1-10 cm or any subrange thereof) outside of the selected one of theone or more discharge ports.

In some embodiments, first end of the lumen extends at least about 1.0mm, about 2.0 mm, about 3.0 mm, about 4.0 mm, about 5.0 mm or more (e.g.in the range of 1-10 mm or any subrange thereof) outside of the firstopening in the pigtail extension.

In another aspect, a method is disclosed including: obtaining a lumen;and inserting the lumen into an intracardiac pump device having a pathfor a guidewire extending through the pump device from a first openingto a second opening. In some embodiments, inserting the lumen includespositioning the lumen such that the lumen extends from a first endlocated outside of the pump device, into the pump device through thefirst opening in the pump device, along the path for the guidewire, outof the pump device through the second opening, and to a second endlocated outside of the pump device. In some embodiments, the lumen isconfigured to receive the guidewire such that when the guidewire passesthrough the lumen from the first end to the second end, the guidewire ispositioned along the path.

In some embodiments, the lumen is configured such that, after theguidewire is received by the lumen and positioned along the path for theguidewire, the lumen may be removed without disturbing the guidewirefrom the path.

Some embodiments include attaching a label to the second end of thelumen, where the label includes instructions for placing the guidewirealong the path using the lumen.

In some embodiments, at least a portion of the lumen has a color whichdiffers from the color of the pump device.

In some embodiments, the lumen is configured to allow the guide wire tobe positioned through the device along the path without substantiallyflexing the guidewire.

In some embodiments, the pump device includes: a proximal drive portionincluding a motor; a distal pump portion connected to a distal end ofthe drive portion; one or more discharge ports positioned between thedrive portion and the pump portion; an inflow cannula connected to thedistal end of the pump portion, the cannula having a distal endincluding an inflow opening; and a flexible tubular pigtail extensionconnected to the distal end of the inflow cannula. In some embodiments,the guidewire path runs through the tubular pigtail extension, from thepigtail extension into the inflow cannula, through the inflow cannulainto the pump portion, and out through a selected one of the one or moredischarge ports. In some embodiments, positioning the lumen includespositioning the lumen such that the lumen extends from a first endlocated outside of the pump device, into the pump device through thefirst opening in the pigtail extension, along the path for theguidewire, out of the pump device through the second opening includingthe selected one of the one or more discharge ports, and to a second endlocated outside of the pump device.

In some embodiments, positioning the lumen includes positioning thelumen such that the second end of the lumen extends at least about 0.1cm, 0.5 cm, 1.0 cm, 2.0 cm, 5.0 cm or more (e.g. in the range of 0.1-10cm or any subrange thereof) outside of the selected one of the one ormore discharge ports.

In some embodiments, positioning the lumen includes positioning thelumen such that the first end of the lumen extends at least about 1 mm,about 2 mm, about 3 mm, about 4 mm, about 5 mm or more (e.g. in therange of 1-10 mm or any subrange thereof) outside of the first openingin the pigtail extension.

In another aspect, a method of loading an intracardiac pump device ontoa guidewire is disclosed including obtaining an apparatus including: theintracardiac pump device having a path for the guidewire extendingthrough the pump device from a first opening to a second opening; and alumen which extends from a first end located outside of the pump device,into the pump device through the first opening in the pump device, alongthe path for the guidewire, out of the pump device through the secondopening, and to a second end located outside of the pump device. In someembodiments, the lumen is configured to receive the guidewire such thatwhen the guidewire passes through the lumen from the first end to thesecond end, the guidewire is positioned along the path.

In some embodiments the method further includes inserting the guidewirethrough the lumen to position the guidewire along the path and removingthe lumen while leaving the guidewire positioned along the path.

Some embodiments include, after removing the lumen, introducing the pumpdevice into a subject using the guide wire.

Various embodiments may include any of the above described features,either alone, or in any suitable combination.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the following drawings and thedetailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate one or more embodiments describedherein and, together with the description, explain these embodiments.Like reference characters refer to the same parts throughout thedifferent views. The drawings are not necessarily to scale, emphasisinstead being placed upon illustrating the principles of theembodiments.

FIG. 1 is an illustration of an intracardiac pump device with a loadinglumen.

FIG. 2 is a photograph of an pump device with a loading lumen.

FIG. 3 is an illustration showing an instruction label for a loadinglumen.

FIG. 4A is an illustration showing the insertion of a guidewire into aloading lumen in an intracardiac pump device.

FIG. 4B is an illustration showing removal of a loading lumen from anintracardiac pump following the insertion of a guidewire into theloading lumen.

FIG. 5 is a photograph of an intracardiac pump loaded onto a guidewire.

FIG. 6 is an illustration of an intracardiac blood pump system.

DETAILED DESCRIPTION

Referring to FIG. 1, an intracardiac pump device 1 is provided that isintended for loading onto a guidewire 4 (e.g., as shown in FIG. 5below). The pump device 1 includes a desired path for the guidewireextending through the pump device from a first opening to a secondopening. A lumen 2 extends from a first end located outside of the pumpdevice 1, into the pump device 1 through the first opening in the pumpdevice 1, along the path for the guidewire 4, out of the pump device 1through the second opening, and terminates at a second end locatedoutside of the pump device 1. In some embodiments, the lumen 2 receivesthe guidewire 4 such that when the guidewire passes through the lumenfrom the first end to the second end, the guidewire is positioned alongthe path.

As detailed below, in some embodiments, the lumen 2 operates such that,after the guidewire is received by the lumen and positioned along thepath for the guidewire, the lumen may be removed without disturbing theguidewire from the path (e.g., resulting in a properly loaded device 1on the guidewire 4, as shown in FIG. 5 below).

In some embodiments, the lumen 2 allows the guide wire 4 to bepositioned through the device 1 along the desired guidewire path withoutsubstantially flexing the guidewire 4, and also protects the device 1from damage during loading onto the guidewire 4.

In various embodiments, the device 1 may include any suitableintracardiac pump device. As shown, the intracardiac pump device 1includes a drive portion 10 and a pump portion 11 coaxial thereto. Thedrive portion 10 includes a motor (not illustrated). The proximal end ofthe drive portion 10 is connected with a catheter 12 holding theelectric lines for operating and controlling the blood pump. The pumpportion 11 is connected with a cannula 30 in the form of an elongateflexible hose whose distal end is provided with a suction head 14 havinginflow openings 15. Contiguous to the suction head 14 is a soft elasticextension 16 that mechanically, yet not hydraulically extends thecannula 30. This extension 16 is provided with a pigtail tip to allowfor atraumatic support on body tissue (as shown the pigtail tip isuncurled). The extension 16 is a hollow tubular member.

The pump portion 11 has a pump ring 20 that is connected with the driveportion 10 through longitudinally extending webs 21. Between the webs21, the discharge ports 22 are situated through which blood exitsradially to then flow along the outer side of the drive portion 10.

Optionally, in some embodiments, a screen 25 is provided at the pumpportion 11. It includes an annular sleeve 26 sitting on the pump ring 20and a continuously flaring guide portion 27 projecting proximally fromthe pump ring. The beginning of the guide portion 27 is at the upstreamend of the discharge ports 22, i.e. at the end adjoining the pump ring20.

In some embodiments, the outer diameter of the drive portion 10 and ofthe pump portion 11 is 4.0 mm. The outer diameter of the optional screen25 is 5.6 to 6.0 mm. The wall thickness of the screen is 0.1 to 0.2 mm.The screen is made of a flexible material, for example of polyurethane.It may be formed integral with the cannula 30.

As shown, the lumen 2 has been inserted into the device 1. The lumenextends from a first end through the extension 16, through the cannula30, through the pump portion 11, and out of one of the discharge ports22 to terminate in a second end outside of the pump device 1. As shown,the pump device 1 is curved, and the lumen 2 extends out through adischarge port 22 located on the inner circumference of the pump device1. The path of the lumen 2 corresponds to the desired guidewire paththrough the device 1.

In various embodiments, the lumen 2 may be made of any suitablematerial, e.g., a plastic or polymer material. In one embodiment, thelumen 2 is made of polyurethane (PU). The lumen 2 can be any suitablesize and shape. In one embodiment (appropriate for use with the Impella2.5 pump available from Abiomed, Inc. of Danvers, Mass.), the lumen 2 isa tubular polyurethane lumen with an inner diameter of 0.55 mm and anouter diameter of 0.75 mm. A lumen of this size fits through the pumpdevice 1 along the desired guidewire path, and is able to receive aguidewire with a diameter of up to 0.4 mm (corresponding to an 0.018inch guidewire, commonly available in the art).

In some embodiments, at least a portion of the lumen has a color whichdiffers from the color of the pump device and/or the color of the guidewire. For example, the lumen 2 may have a bright red exterior, makingthe lumen clearly visible to a user, and providing a visual reminder toremove the lumen 2 prior to introducing the device into the patient.

In various embodiments, the ends of the lumen 2 may extend any suitabledistance outside of the pump device 1. For example. FIG. 2 shows aphotograph of an embodiment featuring the lumen 2 in a pump device 1,where the pump device is an Impella 2.5 pump available from Abiomed,Inc. of Danvers, Mass. As shown, a first end of the lumen 2 extends inthe range of 4-5 mm from the pigtail extension of the pump device 1. Asecond end of the lumen 2 extends about 1 cm from a discharge port ofthe pump device 1.

In some embodiments, first end of the lumen extends at least about 1 mm,about 2 mm, about 3 mm, about 4 mm, about 5 mm or more (e.g. in therange of 1-10 mm or any subrange thereof) from the pigtail extension ofthe device.

In some embodiments, positioning the second end of the lumen extends atleast about 0. 1 cm, 0.5 cm, 1.0 cm, 2.0 cm, 5.0 cm or more (e.g. in therange of 0.1-10 cm or any subrange thereof) from the discharge port.

As shown in FIGS. 1 and 2, in some embodiments, a label 3 is attached tothe lumen 2. The label may include printed or other visual information,including instruction for loading the pump device 1 onto the guidewire 4using the lumen 2. In some embodiments, the size of the label may bechosen to prevent insertion into the patient (e.g., the size may bechosen larger than the typical incision size used in a percutaneousintroduction procedure). This will help ensure that the pump device 1 isnot mistakenly inserted prior to removal of the lumen 2. In someembodiments, the label 3 may be made of a fluid resistant material (e.g.a plastic), and may be attached to the lumen 2 in any suitable fashion(e.g., using an adhesive). In some embodiments the label 3 may be formedintegral with the lumen 2.

FIG. 3 shows an exemplary embodiment of the label 3. As shown the label3 has instruction graphics printed on a front side (shown), and anadhesive on a back side (not shown). The label 3, can be folded aroundthe lumen 3 and caused to adhere to itself, to provide a two sidedflag-like element with visual information appearing on both sides of theflag.

FIGS. 4A and 4B illustrate the loading of the pump device 1 onto theguidewire 4 using the lumen 2. As shown in FIG. 4A, the pigtailextension of the pump device 1 is uncurled. An end of the guidewire 4 isinserted into the end of the lumen 2 extending from the pigtail. Theguidewire 4 is advanced through the lumen 2 until the end of theguidewire exits the other end of the lumen 2 extending from thedischarge port of the pump. Note that during insertion of the guidewire4, the lumen 2 serves to prevent flexing of the guidewire, and protectsthe internal parts of the pump device.

As shown in FIG. 4B, once the end of the guidewire 4 has passed throughthe lumen 2, the lumen 2 may be removed, leaving the guidewire behind,positioned along the desired guidewire path. The lumen 2 is pulled overthe guidewire towards the end extending from the discharge port untilthe lumen 2 completely exits the pump device 1 and comes clear off theguidewire 4. In some embodiments, the lumen 2 is then discarded.

In some embodiments, the pump device 1 may be shipped to an end userwith the lumen 2 already installed. Accordingly, the positioning of thelumen 2 along the desired guidewire path may undergo quality control.The lumen 2 then acts as a guide for the end use during loading on theguidewire 4, resulting in reduced user error. For example, the use ofthe lumen 2 can reduce or eliminate errors related to passing theguidewire through an incorrect discharge port on the pump device 1.

FIG. 5 is a photograph of the pump device 1 loaded on the guidewire 4after the lumen 2 has been completely removed. The pump device 1 can nowbe introduced into a patient using the guidewire, e.g., as describedbelow with reference to FIG. 6.

FIG. 6 shows a catheter system 700 with an intracardiac blood pump 1.The pump may be, for example the Impella 2.5 blood pump available fromAbiomed Inc. of Danvers, Mass. The blood pump 1 is a catheter mountedmicroaxial flow pump capable of pumping up to, e.g., 2.5 L/min of bloodfrom the left ventricle to the systemic circulation. Using a monorailtype insertion platform, the blood pump 1 is placed via a femoralarterial sheath 703 (e.g., a 13 Fr sheath). The cannula portion 710 ofthe device which, during use, sits across the aortic valve is contiguousto and integrated motor 704 that comprises the largest diameter sectionof the catheter (e.g., at 12 Fr). A repositioning device 705 allowsremoval of the sheath 703 after placement, leaving the modest (e.g. 9F)catheter in the arterial system. The pump 1 is powered and controlled bya control console (not shown), e.g., an Impella series control panelavailable from Abiomed Inc. of Danvers, Mass. An arterial infusion pump(not shown) controls a purge system designed to keep the corrosiveplasma from entering the motor compartment of the pump 1.

The pump 1 is inserted via a modified monorail technique under directfluoroscopic control. Pressure monitoring using a pressure lumen 708adjacent to the motor as well as motor current monitoring are used togive positioning verification to the operator. The device is placedusing fluoroscopic control to avoid kinking the catheter andcompromising the purge lumen. After arterial access is obtained, the 13F peel-away sheath is positioned. A coronary guiding catheter (e.g., aJR-4 cathether) and subsequently a 0.018″ wire is placed across theaortic valve into the left ventricle. Once the 0.018″ wire is across theaortic valve, the guiding catheter is removed and the pump catheter isthreaded onto the 0.018″ wire, e.g., using the loading lumen 2 (notshown) as described in detail above. With the device positioned in theventricle (as shown in FIG. 8), the wire is removed and the pump 1activated at minimum level, just enough to counteract the regurgitationcoming down the cannula from the proximal aorta into the ventricle nowthat the cannula is placed across the aortic valve.

Once the pump 1 is positioned across the aortic valve, the control panelcan be utilized to confirm that the device placement is proper andstable. At this point, the device performance level is typicallyadjusted to a higher performance level.

Further details regarding the use of the system 700 may be found in D.H. Raess and D. M. Weber, J. of Cariovasc. Trans. Res. (2009) 2:168-172.

Although a number of examples have been given above related to guidewireloading lumens used with intracardiac blood pumps, it is to beunderstood that the techniques applied herein may be used for otherapplications, including the guidewire loading of any other suitabletypes of medical devices intended for use on human or animal subjects.

The scope of the present invention is not limited by what has beenspecifically shown and described hereinabove. Those skilled in the artwill recognize that there are suitable alternatives to the depictedexamples of materials, configurations, constructions and dimensions.Numerous references, including patents and various publications, arecited and discussed in the description of this invention. The citationand discussion of such references is provided merely to clarify thedescription of the present invention and is not an admission that anyreference is prior art to the invention described herein. All referencescited and discussed in this specification are incorporated herein byreference in their entirety.

While various inventive embodiments have been described and illustratedherein, those of ordinary skill in the art will readily envision avariety of other means and/or structures for performing the functionand/or obtaining the results and/or one or more of the advantagesdescribed herein, and each of such variations and/or modifications isdeemed to be within the scope of the inventive embodiments describedherein. More generally, those skilled in the art will readily appreciatethat all parameters, dimensions, materials, and configurations describedherein are meant to be exemplary and that the actual parameters,dimensions, materials, and/or configurations will depend upon thespecific application or applications for which the inventive teachingsis/are used. Those skilled in the art will recognize, or be able toascertain using no more than routine experimentation, many equivalentsto the specific inventive embodiments described herein. It is,therefore, to be understood that the foregoing embodiments are presentedby way of example only and that, within the scope of the appended claimsand equivalents thereto, inventive embodiments may be practicedotherwise than as specifically described and claimed. Inventiveembodiments of the present disclosure are directed to each individualfeature, system, article, material, kit, and/or method described herein.In addition, any combination of two or more such features, systems,articles, materials, kits, and/or methods, if such features, systems,articles, materials, kits, and/or methods are not mutually inconsistent,is included within the inventive scope of the present disclosure.

The above-described embodiments can be implemented in any of numerousways. For example, the embodiments may be implemented using hardware,software or a combination thereof When implemented in software, thesoftware code can be executed on any suitable processor or collection ofprocessors, whether provided in a single computer or distributed amongmultiple computers.

Also, various inventive concepts may be embodied as one or more methods,of which an example has been provided. The acts performed as part of themethod may be ordered in any suitable way. Accordingly, embodiments maybe constructed in which acts are performed in an order different thanillustrated, which may include performing some acts simultaneously, eventhough shown as sequential acts in illustrative embodiments.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

The phrase “or,” as used herein in the specification and in the claims,should be understood to mean “either or both” of the elements soconjoined, i.e., elements that are conjunctively present in some casesand disjunctively present in other cases. Multiple elements listed with“or” should be construed in the same fashion, i.e., “one or more” of theelements so conjoined. Other elements may optionally be present otherthan the elements specifically identified by the “or” clause, whetherrelated or unrelated to those elements specifically identified. Thus, asa non-limiting example, a reference to “A or B”, when used inconjunction with open-ended language such as “including” can refer, inone embodiment, to A only (optionally including elements other than B);in another embodiment, to B only (optionally including elements otherthan A); in yet another embodiment, to both A and B (optionallyincluding other elements); etc.

As used herein in the specification and in the claims, “or” should beunderstood to have the same meaning as “or” as defined above. Forexample, when separating items in a list, “or” or “or” shall beinterpreted as being inclusive, i.e., the inclusion of at least one, butalso including more than one, of a number or list of elements, and,optionally, additional unlisted items. Only terms clearly indicated tothe contrary, such as “only one of” or “exactly one of,” or, when usedin the claims, “consisting of,” will refer to the inclusion of exactlyone element of a number or list of elements. In general, the term “or”as used herein shall only be interpreted as indicating exclusivealternatives (i.e. “one or the other but not both”) when preceded byterms of exclusivity, such as “either,” “one of,” “only one of,” or“exactly one of.” “Consisting essentially of,” when used in the claims,shall have its ordinary meaning as used in the field of patent law.

In the claims, as well as in the specification above, all transitionalphrases such as “including,” “including,” “carrying,” “having,”“containing,” “involving,” “holding,” “composed of,” and the like are tobe understood to be open-ended, i.e., to mean including but not limitedto. Only the transitional phrases “consisting of” and “consistingessentially of” shall be closed or semi-closed transitional phrases,respectively, as set forth in the United States Patent Office Manual ofPatent Examining Procedures, Section 2111.03.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

Variations, modifications and other implementations of what is describedherein will occur to those of ordinary skill in the art withoutdeparting from the spirit and scope of the invention. While certainembodiments of the present invention have been shown and described, itwill be obvious to those skilled in the art that changes andmodifications may be made without departing from the spirit and scope ofthe invention. The matter set forth in the foregoing description andaccompanying drawings is offered by way of illustration only and not asa limitation.

What is claimed is:
 1. An apparatus comprising: an intracardiac pumpdevice having a path for a guidewire extending through the pump devicefrom a first opening to a second opening; and a lumen which extends froma first end located outside of the pump device, into the pump devicethrough the first opening in the pump device, along the path for theguidewire, out of the pump device through the second opening, to asecond end located outside of the pump device; wherein the lumen isconfigured to receive the guidewire such that when the guidewire passesthrough the lumen from the first end to the second end, the guidewire ispositioned along the path.
 2. The apparatus of claim 1, wherein theintracardiac pump device comprises: a proximal drive portion comprisinga motor; and a distal pump portion connected to a distal end of thedrive portion;
 3. The apparatus of claim 2, wherein the intracardiacpump device comprises one or more discharge ports positioned between thedrive portion and the pump portion.
 4. The apparatus of claim 2, whereinthe lumen is configured such that, after the guidewire is received bythe lumen and positioned along the path for the guidewire, the lumen maybe removed without disturbing the guidewire from the path.
 3. Theapparatus of claim 2, further comprising a label attached to the secondend of the lumen, wherein the label includes instructions for placingthe guidewire along the path using the lumen.
 4. The apparatus of claim2, wherein at least a portion of the lumen has a color which differsfrom the color of the pump device.
 5. The apparatus of claim 2, whereinthe lumen is configured to allow the guidewire to be positioned throughthe device along the path without substantially flexing the guidewire.6. The apparatus of claim 2, wherein a first outer diameter of theproximal drive portion and second outer diameter of the distal pumpportion are 4.0 mm
 7. The apparatus of claim 2, wherein the intracardiacpump device includes a microaxial flow pump.
 8. The apparatus of claim7, wherein the microaxial flow pump is configured to pump blood at aflow rate of at least 2.5 L/min.
 9. The apparatus of claim 2, furthercomprising: an inflow cannula connected to the distal end of the pumpportion, the cannula having a distal end comprising an inflow opening;and a flexible tubular pigtail extension connected to the distal end ofthe inflow cannula, and
 10. The apparatus of claim 9, wherein theguidewire path runs through the tubular pigtail extension, from thepigtail extension into the inflow cannula, through the inflow cannulainto the pump portion, and out through a selected one of the one or moredischarge ports
 11. An intracardiac pump device comprising: a pumpportion having a path for a guidewire extending through the pump portionfrom a first opening in the pump portion to a second opening in the pumpportion; and a lumen positioned in the pump portion, the lumen extendingfrom a first end of the lumen through the first opening in the pumpportion, along the path for the guidewire, and out of the pump portionthrough the second opening in the pump portion to a second end locatedoutside of the pump portion, wherein the lumen is configured to receivethe guidewire such that when the guidewire passes through the lumen fromthe first end of the lumen to the second end of the lumen, the guidewireis positioned along the path.
 12. The intracardiac pump of claim 11,wherein the intracardiac pump device comprises: a proximal drive portioncomprising a motor; a distal pump portion connected to a distal end ofthe drive portion;
 13. The intracardiac pump of claim 12, wherein theintracardiac pump device comprises one or more discharge portspositioned between the drive portion and the pump portion.
 14. Theintracardiac pump device according to claim 13, wherein the lumen isremovably positioned in the pump portion, such that, after the guidewireis received by the lumen and positioned along the path for theguidewire, the lumen may be removed from the pump portion withoutdisturbing the guidewire from the path through the pump portion.
 15. Theintracardiac pump device according to claim 13, wherein the secondopening in the pump portion is a discharge port of the pump portion. 16.The intracardiac pump of claim 11, wherein at least a portion of thelumen has a color which differs from the color of the pump device. 17.The intracardiac pump of claim 11, wherein the lumen is configured toallow the guide wire to be positioned through the device along the pathwithout substantially flexing the guidewire.
 18. The intracardiac pumpof claim 11, wherein the second end of the lumen extends at least about1 cm outside of the selected one of the one or more discharge ports. 19.The intracardiac pump of claim 11, wherein the first end of the lumenextends at least about 4 mm outside of the first opening in the pigtailextension.